Zdrowie i gospodarka · 04/08/2010

FDA Announces Prescription Drug User Fee Rates for Fiscal Year 2011

The US Food and Drug Administration (FDA) has set the rates for prescription drug user fees for the fiscal year 2011, with the goal of generating one-third of the fee revenues from each category: applications, establishments, and products. The fee rates, which went into effect on October 1, 2010, include $1,542,000 for applications requiring clinical data, $771,000 for applications not requiring clinical data, $497,200 for establishment fees, and $86,520 for product fees.